Junior Regulatory Affairs Specialist

Junior Regulatory Affairs Specialist – Regulatory Team

Location: Warsaw (hybrid model).

Fixed-term position – maternity replacement.

Responsibilities

• Support RA team members ensuring compliance during uploading of relevant data into RA databases, internal systems, and platforms.
• Under supervision, maintain assigned, authorized products through timely submission of variations.
• Under supervision, ensure high quality labelling translation and artwork management in appropriate systems.
• Collect publicly available regulatory information (regulatory intelligence) and keep relevant persons appropriately informed.
• Ensure regulatory files and archives are kept updated and complete.
• Keep abreast of local and international laws in the regulatory environment.

Qualifications, Skills & Experience

• Education: B.Sc. in pharmacy or other life science or equivalent (not required, but advantage).
• Experience in the pharmaceutical industry preferable, in regulatory, medical, or laboratory position.
• Excellent verbal and written communication, good organizational and planning skills.
• Meticulous attention to detail and ability to handle conflicting time pressures and a large volume of work.
• Ability to work both independently and as part of a team, concentrating on large volumes of written/paper-based work in an office environment.
• Proficiency in Polish and English; proficiency in PC use: word-processing, spreadsheets, databases, internet.
• Experience in a regulatory department handling registration aspects is an advantage.

Required Skills

• Adaptability
• Biopharmaceutical Industry
• Client Registration
• Communication
• Database Applications
• Databasing
• Detail-Oriented
• International Human Rights Law
• International Regulatory Compliance
• Pharmaceutical Regulatory Affairs
• Pharmacovigilance
• Regulatory Affairs Compliance
• Regulatory Affairs Management
• Regulatory Communications
• Regulatory Compliance
• Regulatory Experience
• Regulatory Reporting
• Regulatory Strategy Development
• Regulatory Submissions

Employment Details

• Employee Status: Project Temps (Fixed Term)
• Work Arrangement: Hybrid